Pratik Modi Email & Phone Number

Ahmedabad, Gujarat, India

• Responsible for Vendor Qualification Activity and review of Vendor Evaluation Reports of materials in reference of Approved Manufacturer List.• To maintain Quality Agreements.• To maintain Internal Audit Schedule and responsible for doing Internal Audits as per schedule.• Qualification of Contract Service Providers.• Review of Laboratory Incidents, Out of Specifications, Out of Alert Limits, Corrective Action and Preventive Actions related to Quality Control… Show more • Responsible for Vendor Qualification Activity and review of Vendor Evaluation Reports of materials in reference of Approved Manufacturer List.• To maintain Quality Agreements.• To maintain Internal Audit Schedule and responsible for doing Internal Audits as per schedule.• Qualification of Contract Service Providers.• Review of Laboratory Incidents, Out of Specifications, Out of Alert Limits, Corrective Action and Preventive Actions related to Quality Control department.• Review and Assessment of Change Controls.• Review of Audit trails for Instruments, Equipments and Softwares with respect to Quality Control Laboratory.• To maintain, review and investigate Raw materials and Packaging Materials Complaints.• Responsible for review and approval of Stability Protocols.• To review Installation Qualification, Operational Qualification and Performance Qualification of Instruments, Equipments with respect to Quality Control Laboratory.• Responsible for Approval of Finished Product COAs, Raw Material COAs, Packaging Material COAs, Stability Product COAs and Stability Summeries. Show less

Anklesvar, Gujarat, India

• Daily planning related to In process samples, finished samples, stability samples and raw materials.• Review of analytical test data sheets and all related quality documents, preparation and review of analytical method validation protocols and reports.• Actively participate in regulatory audit as well as customer audits.• Responsible to provide Audit reports under guidance of QC Manager.• Ensure timely completion activity of CAPA (Corrective & Preventive… Show more • Daily planning related to In process samples, finished samples, stability samples and raw materials.• Review of analytical test data sheets and all related quality documents, preparation and review of analytical method validation protocols and reports.• Actively participate in regulatory audit as well as customer audits.• Responsible to provide Audit reports under guidance of QC Manager.• Ensure timely completion activity of CAPA (Corrective & Preventive Actions).• Handling of change control activity.• Responsible for daily release of Finished Product as per dispatch schedules.• To actively participate in investigation of laboratory incidents and Out of specifications.• To troubleshoot related to HPLC, GC, UV, KF, Autotitrator etc. • Timely release the instrument after preventive maintenance and then calibration schedule (Planned or Unplanned).• To provide timely support to analyst (i.e. requirements like chemicals, impurities, glassware, instruments for analysis etc) to achieve production target on time. Show less

Vadodara, Gujarat, India

• Analysis of In-process, finished and stability samples as per priority (Test-Assay, CU, Related substances, Residual solvents, Dissolution, Water by KF).• Trouble shooting of instruments like HPLC, GC, UV, KF and Dissolution.• Preparations of Certificate of analysis, test data sheet and specifications.• Responsible for daily release of Finished Product as per dispatch schedules.

Aurangabad, Maharashtra, India

• Analysis of In-process, finished and stability samples as per priority (Test-Assay, CU, Dissolution, Water by KF).• Responsible for receiving of all the samples and generation of Analytical reference number for individual. • Responsible for daily release of water samples.• Preparations of Certificate of analysis, test data sheet and specifications.